NCT04535089

Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children

Opioid Sparing Analgesia: Intraoperative Infusion Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Perioperative pain control is necessary in children as inadequate treatment may lead to progression of perception of pain and development of chronic pain in the future. Anesthetists tend to adopt approach to perioperative control of pain by non-opioid drugs that mediate pain modulation. Its use as opioid sparing analgesia in different surgeries leading to mixed results.

Detailed description

Site of study: This study will be carried out in neurosurgical operating rooms of Zagazig University Hospitals. b. Sample size: A pilot study was done to estimate percent of children need intraoperative fentanyl was (10%) for dexmedetomidine group, and ( 40%) for lidocaine group, at 0.05 α error and 0.2 β error . Sample size was calculated using Open Epi software, is 32 children in each group.

Conditions

• Analgesia

Interventions

Type	Name	Description
DRUG	Dexmedetomidine injection	receive IV bolus dose of 0.5 ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5 ug/kg/h
DRUG	Lidocaine Iv	IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2020-09-01
• Last updated: 2021-12-02

Locations

1 site across 1 country: Egypt